NA 329.607Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982192103), received between Feb 27, 2019 and Oct 28, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 DURING THE SURGERY THE MALLEABLE TEMPLATE BEING USED TO ADAPT IT TO THE PATIENT'S ANATOMY, WAS BROKEN WHEN THE TONGUE WAS FOLDED. IT WAS ALREADY WEAK ENOUGH TO BREAK. THIS REPORT IS FOR ONE (1) BEND-TEMPL SM L69. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247054 ↗
• MalfunctionFeb 27, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, THE DISTRIBUTOR RECEIVED THE BENDING TEMPLATE TO DELIVER TO THE HOSPITAL FOR A SURGERY PLANNED ON (B)(6). HOWEVER, THE DISTRIBUTOR FOUND OUT THAT THE BENDING TEMPLATE WAS BROKEN WHEN IT WAS RECEIVED IN A LOAN SET. ANOTHER DEVICE WAS ARRANGED BEFORE DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8376063 ↗